BACKGROUND At the U.S. Food and Drug Administration (FDA), the mission of the Center for Devices and Radiological Health (CDRH) is to ensure that all patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Although the CDRH has observed enrollment differences in some clinical trials, no systematic analysis has been conducted regarding enrollment differences in baseline demographics, to our knowledge. METHODS The CDRH has summarized information on study participants and their baseline demographics in public-facing documentation for all authorized medical devices that involved orthopaedic clinical studies from 1985 to 2020. Descriptive analyses and exploratory statistical testing have been conducted to investigate the reported percentages by sex and race compared with those reported in the U.S. National Census and the American Joint Replacement Registry (AJRR), respectively. RESULTS We identified 94 submissions and corresponding combined clinical trials from 261 original clinical study arms with 34,193 participants. Most of the submissions reported age and sex, while only 36 submissions (38.3%) reported racial demographics. Among the 88 trials providing enrollment by sex, the female enrollment percentage ranged from 22.2% to 88.7%, with a mean of 55.0%. In the submissions that reported racial data (38.3%), White and Black patients had a mean enrollment of 89.2% (range, 64.8% to 98.7%) and 6.2% (range, 0.4% to 20.7%), respectively. The enrollment for other minority groups ranged from 0% to 3.0%. These clinical trials have shown numerically lower female representation (55.0%) but higher White representation (89.2%) than what has been reported in the AJRR. The other racial groups have participated much less than their corresponding percentages in the U.S. population, but they are similarly represented in the AJRR. CONCLUSIONS The clinical trials supporting the FDA's authorization of orthopaedic devices had a wide range of sex and racial enrollments. It appears that female enrollment mirrors the percentage of women in the U.S. population. However, despite prior efforts, some racial groups are still underrepresented. The FDA has made a commitment to advancing health equity as part of the 2022-2025 Strategic Priorities of the CDRH. We hope that the results of this study will help health-care professionals make informed clinical decisions when using medical devices.

中文翻译：

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美国 FDA 授权的骨科器械临床研究中 35 年的性别和种族报告。


背景 在美国食品药品监督管理局 （FDA），器械和放射健康中心 （CDRH） 的使命是确保所有患者和提供者都能及时、持续地获得安全、有效和高质量的医疗器械和安全的辐射发射产品。据我们所知，尽管 CDRH 在一些临床试验中观察到了入组差异，但尚未对基线人口统计学的入组差异进行系统分析。方法 CDRH 在 1985 年至 2020 年涉及骨科临床研究的所有授权医疗器械的面向公众的文件中总结了有关研究参与者及其基线人口统计数据的信息。已经进行了描述性分析和探索性统计测试，以调查与美国全国人口普查和美国关节置换登记处 （AJRR） 分别报告的百分比相比，按性别和种族划分的百分比。结果： 我们从 261 个原始临床研究组中确定了 94 项提交和相应的联合临床试验，涉及 34,193 名参与者。大多数提交的内容报告了年龄和性别，而只有 36 份提交的内容 （38.3%） 报告了种族人口统计数据。在按性别提供入组的 88 项试验中，女性入组百分比从 22.2% 到 88.7% 不等，平均为 55.0%。在报告种族数据 （38.3%） 的提交中，白人和黑人患者的平均入组率分别为 89.2%（范围，64.8% 至 98.7%）和 6.2%（范围，0.4% 至 20.7%）。其他少数群体的入学率从 0% 到 3.0% 不等。这些临床试验显示，女性代表人数 （55.0%） 高于 AJRR 中报告的人数 （89.2%），但白人代表人数较高。 其他种族群体的参与率远低于他们在美国人口中的相应百分比，但他们在 AJRR 中的代表性相似。结论 支持 FDA 授权骨科器械的临床试验涉及广泛的性别和种族入组。女性入学率似乎反映了女性在美国人口中的百分比。然而，尽管之前做出了努力，但一些种族群体的代表性仍然不足。FDA 已承诺促进健康公平，作为 CDRH 2022-2025 年战略重点的一部分。我们希望这项研究的结果能帮助医疗保健专业人员在使用医疗器械时做出明智的临床决策。